Efficacy of Hyaluronic Acid in Prevention of Acute Radiation Proctitis

Acute Radiation Enteritis Clinical Trial

Official title:

Efficacy of Hyaluronic Acid in Prevention of Acute Radiation Proctitis: Multi-center, Double-blind, Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06469216
• Other study ID #: 05-2023-018
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: April 1, 2024
• Est. completion date: October 2025

Study information

• Verified date: June 2024
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A randomized placebo-controlled clinical trial to evaluate efficacy of hyaluronic acid in prevention of acute radiation proctitis among oncology patient population especially who are diagnosed with abdomeno-pelvic tumors and subsequently required radiotherapy.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 42
• Est. completion date: October 2025
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• All patients diagnosed with pelvic or gastrointestinal malignancies (tumors in uterus, cervix, prostate, seminal vesicles, kidney, colon, etc.),
• All patients who required adjuvant or radical radiation therapy;
• Age < 80 years;
• Karnofsky Performance Status = 60

Exclusion Criteria:

• Patients were excluded if they had
• gt; previous pelvic radiotherapy,
• gt; inflammatory bowel disease or
• gt; rectal issues (e.g., haemorrhoids).
• Patients diagnosed with cancer rectum

Related Conditions & MeSH terms

• Acute Radiation Enteritis
• Enteritis
• Proctitis

Intervention

Drug:
• Hyaluronic Acid
Hyaluronic Acid to be used as sodium hyaluronate powder plus inactive ingredient (Carboxy methyl cellulose) and to be dissolved in distilled water

Other:
• Placebo
Inactive ingredient (Carboxy methyl cellulose) to be used as powder and to be dissolved in distilled water

Locations

Country	Name	City	State
Egypt	Ahmed Maher teaching hospitals	Cairo
Egypt	Al-Ahrar teaching hospital	Zagazig	Sharqia

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time (in days) to occurrence of Acute Radiation Proctitis		for each patient: time from the first day of radiation therapy for up to 3 months